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Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02800928
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Sherry McKee, Yale University

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior.

Condition or disease Intervention/treatment Phase
Smoking Drug: CERC-501 Drug: Placebo Phase 2

Detailed Description:

The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.

The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.

Each period of the crossover consists of a 7-day out-patient treatment period followed by a single out-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : January 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: CERC-501
Administered orally once daily, 10mg daily, 8 days
Drug: CERC-501

Placebo Comparator: Placebo
Administered orally daily, 8 days
Drug: Placebo

Primary Outcome Measures :
  1. Latency [ Time Frame: 50 min ]
    Latency (in minutes and seconds) to time of first cigarette smoking during the delay period

  2. Number of Cigarettes Smoked [ Time Frame: 60 min ]
    Number of cigarettes smoked during the self administration period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  1. Provides written informed consent and agrees to complete required clinic visits
  2. Male or female 21 to 60 years of age inclusive
  3. Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
  4. Smokes at least 10 cigarettes per day on average for the past 6 months
  5. Fagerstrom score ≥3 at screening
  6. Currently not seeking smoking cessation therapy
  7. Urine dip test for cotinine concentration >150 ng/mL
  8. In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 10- or 12 lead ECG, vital signs, and clinical laboratory testing)
  9. Able to read, write, and speak English
  10. Females must be either:

    1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
    2. Women of childbearing potential (WOCBP) must meet the criteria below:

    i. Uses an acceptable double-barrier method of contraception as determined by the Investigator -and- ii. Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period.

  11. Male subjects must agree to use a condom if partner is of childbearing potential

Exclusion Criteria

  1. Have used tobacco or other nicotine containing products other than cigarettes (e.g., nicotine patches, pipe, cigars, snuff, chewing tobacco or e-cigarettes) within the past 30 days
  2. Any substance use disorder other than nicotine or caffeine as assessed by the Structured Clinical Interview-IV Axis I Disorders (SCID) for Diagnostic and Statistical Manual of Mental Disorders (DSM)
  3. Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
  4. Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the SCID-IV
  5. Current psychiatric conditions that interfere with study conduct, assessment, or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc. We will screen for worsening of symptoms of depression and/or suicidality at each medication appointment and lab sessions by having participants complete the Beck Depression Inventory (BDI) and the Columbia-Suicide Severity Rating Scale (C-SSRS). If there is a worsening of symptoms of depression and/or suicidality, the participants will speak a licensed psychologist for evaluation.
  6. Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
  7. Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Study MD (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
  8. Clinically significant clinical laboratory test taken during screening
  9. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the upper limit of normal (ULN)
  10. Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
  11. Positive ethanol breath test at screening or prior to dosing on Days 1 and 8 of each treatment period
  12. Positive urine drug test at screening or and/or prior to dosing on Days 1 and 8 of each treatment period except for cannabis
  13. History of severe allergies or multiple adverse drug reactions
  14. Known hypersensitivity to CERC-501
  15. Current use of a proton pump inhibitor or histamine 2 blocker
  16. Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study
  17. Current use of any psychoactive medications including: antipsychotics, benzodiazepines, mood stabilizers, selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) or other antidepressants mood stabilizers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02800928

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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
Janssen Pharmaceuticals
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Principal Investigator: Sherry McKee, PhD Yale University
  Study Documents (Full-Text)

Documents provided by Sherry McKee, Yale University:
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Responsible Party: Sherry McKee, Professor, Yale University Identifier: NCT02800928    
Other Study ID Numbers: 1602017291
P50DA033945 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2016    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No